FDA.reportPublic FDA data

Karl Schumacher

Primary DI
00842517117877
Brand
Karl Schumacher
Company
Karl Schumacher Dental, LLC
Model
TUB0002
Device description
Autoclavable Silicone Tubing, Per Ft
Published
2024-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EHZEvacuator, oral cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHZEvacuator, Oral CavityDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842517117877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842517117877008425171178778425171178770842517117877

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation tubing, reusableA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)523-2427custsvs@karlschumacher.com

Regulatory Flags#

DUNS number
101070070
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842517104747Karl SchumacherASP0016T2025-07-08
00842517112360Karl SchumacherNEE00022025-07-08
00842517112384Karl SchumacherNEE00062025-07-08
00842517112421Karl SchumacherNEE00082025-07-08
00842517112438Karl SchumacherNEE0008T2025-07-08
00842517112476Karl SchumacherNEE00112025-07-08
00842517112483Karl SchumacherNEE00122025-07-08
00842517116764Karl SchumacherSCI0667S2025-06-19
00842517108547Karl SchumacherELX0012L2024-03-18
00842517108554Karl SchumacherELX0012R2024-03-18
00842517108561Karl SchumacherELX0013L2024-03-18
00842517108578Karl SchumacherELX0013R2024-03-18
00842517108622Karl SchumacherELX03202024-03-18
00842517108639Karl SchumacherELX03212024-03-18
00842517108660Karl SchumacherELX03502024-03-18
00842517108677Karl SchumacherELX03512024-03-18
00842517104129Karl SchumacherASP0000Y2025-04-23
00842517112568Karl SchumacherNEE06862025-04-23
00842517112582Karl SchumacherNEE06892025-04-23
00842517112599Karl SchumacherNEE06902025-04-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00723896029848Practicon Color Splash™ Saliva Ejectors 100/PackPRACTICON, INC.EHZ2026-01-08
10371347017790Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
10371347017806Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
10371347017813Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
10371347017820Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-11-18
00371347018448Advance Dental ProductsThe Atlanta Dental Supply CompanyEHZ2025-03-04
TQ26ST2553121Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553211Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553311Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553411Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553521Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553621Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553721Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
TQ26ST2553921Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHZ2024-12-09
10080196553686MEDLINEMEDLINE INDUSTRIES, INC.EHZ2024-09-19
10889950144838Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10889950144845Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10889950144852Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10889950144869Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10889950144876Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10889950144883Hu-FriedyHU-FRIEDY MFG. CO., LLCEHZ2024-08-15
10888277652941MedlineMEDLINE INDUSTRIES, INC.EHZ2024-01-24
D248B101051Saliva Ejector Tip (Gray) - Pack of 10HAGER WORLDWIDE, INC.EHZ2023-09-12
D248B101081Saliva Ejector Tip (Gray) - Pack of 3HAGER WORLDWIDE, INC.EHZ2023-09-12
D248B101120Serviceable Saliva EjectorHAGER WORLDWIDE, INC.EHZ2023-09-12
10889950140717HuFriedyGroupHU-FRIEDY MFG. CO., LLCEHZ2023-05-26
10889950140724HuFriedyGroupHU-FRIEDY MFG. CO., LLCEHZ2023-05-26
H668D6401141PearsonKeystone IndustriesEHZ2023-02-20
H668D6401151PearsonKeystone IndustriesEHZ2023-02-20
H668D6401211PearsonKeystone IndustriesEHZ2023-02-20